Study of Sc-FOS for Pouchitis Prevention

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Pouchitis

Treatments: Drug: Maltodextrin; Drug: Short-Chain Fructooligosaccharide

Study type: Interventional

Funder types: Other

Identifiers

NCT02203955

14-001220

Details and patient eligibility

About

The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-65 years.
2. History of ulcerative colitis
3. Ileostomy closure after IPAA
4. Ability to give appropriate consent

Exclusion criteria

1. Crohn's disease.
2. Perianal disease (including abscess, fissure, or stricture)
3. Pregnancy
4. Lactation
5. Concurrent treatment for IBD or pouchitis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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13 participants in 2 patient groups, including a placebo group

Short-Chain Fructooligosaccharide

Active Comparator group

Description:

4 chews (8.0 g scFOS) orally per day for 12 months

Treatment:

Drug: Short-Chain Fructooligosaccharide

Maltodextrin

Placebo Comparator group

Description:

4 chews (maltodextrin) daily for 12 months

Treatment:

Drug: Maltodextrin